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Quality Assurance Specialist (Product Quality)

Quality Assurance Specialist (Product Quality)

IntuitiveTokyo, JAPAN, JP
30+ days ago
Job description

At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Primary Function of Position :

  • Manage and implement required actions to maintain existing product lines and to solve any product quality issues occurred in Japanese market.
  • Take timely and appropriate quality management actions and executing communications with government and internal / external customers.

Roles and Responsibilities :

This position has mainly following responsibilities and authorities to timely deliver effective and safety products in Japanese market, to reduce customer complaint / malfunction, and to improve product quality :

  • Lead risk management team and implement risk management activities from the viewpoint of product and subcontractors / suppliers in cooperation with related functions.
  • Assess change notifications from headquarters and manufacturing sites, and implement necessary actions in cooperation with related functions.
  • Evaluate customer complaints from the viewpoint of product quality, report to ISI and manufacturing sites, and evaluate the analysis result in cooperation with Safety Control team. Furthermore, create customer letters, and communicate to customers to solve the quality issue with Marketing, Sales, Field Service and Safety Control teams.
  • Completing quality issues by working with regulatory agencies, customers and related functions.
  • Collaborate with Product Quality team and Safety Control team to reduce customer complaints from the viewpoint of product.
  • Involve in implementation of a field action like a recall.
  • Collaborate with QRC team to maintain Quality Management System.
  • Work related to product realization (control DMRs and materials for released products etc.)
  • Operate product release (IQC, labeling instructions, and market release assessment etc.)
  • Manage non-conforming products (rework, concession, and hold etc.)
  • Work related to data analysis and CAPA.

    • Skill / Job Requirements :

  • Education : Bachelor or higher degree (Preferred : Physics, Chemistry, Biology, Material Engineering, Electrical Engineering, Mechanical Engineering or Pharmacology)
  • Background : Minimum 3 years experience in Pharmaceutical / Medical Device / IVD industries
  • Minimum 3 years experience related to Quality in any manufacturing industries
  • Skill / Experience : Must : Good interpersonal / communication skill to work well with cross-functional teamsAnalytical mindset and ability to see the big pictureProject management skillLogical thinking skillStrong willing to achieve goalsVerbal and written communication in English and JapaneseKnowledge of basic Quality Management System ( ISO 9001) / Quality Assurance / Quality Control methodologyBasic PC skill ( Microsoft Word / Excel / Powerpoint)
  • Preferred : Knowledge of J-PMD Act, relevant regulations, ISO 13485 and ISO 14971Experience of complaint handling and / or complaint product investigationExperience of using Oracle Agile PLM, SAP, Trackwise, and / or HP ALM
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    Assurance Specialist • Tokyo, JAPAN, JP